Phase II Study to Evaluate Stereotactic Body Radiation Therapy For Palliative Management of Unresectable Recurrent or Residual Pancreatic or Periampullary Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Late Gastrointestinal Toxicities
研究概览
简要总结
The investigators are looking to see if a certain dose of stereotactic body radiation therapy (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary adenocarcinoma.
详细描述
No standard treatment option has yet been established for patients with recurrent or residual disease after definitive treatment of pancreatic or periampullary cancers (duodenal, ampullary, bile duct). Linac based stereotactic body radiation therapy (SBRT) administered in 1-3 fractions has been shown to be an effective treatment option for patients with unresectable, locally advanced pancreatic adenocarcinoma, achieving local control rates of 84-92% at one year. Associated late gastrointestinal toxicity rates have been reported to be 22-25% at 1 year. We hypothesize that similarly excellent local control rates (80-90% at one year) with a reasonable rate of toxicity (≤20%) can be achieved using Linac based SBRT delivered as 5 Gy x 5 for patients with local failure (remaining disease) after previous treatment with conventional chemoradiation therapy (CRT) with or without surgery and as 6.6 Gy x 5 for radiation-naïve patients with local failure (remaining disease) after previous treatment with surgery and/or chemotherapy. The toxicities of note for this trial are grade 2 and greater gastritis, fistula, enteritis, ulcer, or any other grade 3 or greater gastrointestinal toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Karnofsky Performance Status greater than or equal to 70%
- •confirmed pancreatic or periampullary adenocarcinoma
- •pancreatic or periampullary tumor less than 8.0 cm in greatest axial dimension
- •standard of care treatment for pancreatic cancer that included radiation therapy
- •* patients may be receiving continued chemotherapy post initial CRT. or
- •standard of care treatment for pancreatic cancer that did not include radiation therapy * patients must have attempted chemotherapy upon initial diagnosis
- •acceptable organ and marrow function as determined by blood tests
- •ability to understand and give consent
- •must be a patient to be treated with SBRT only at Johns Hopkins Hospital
- •life expectancy of greater than 3 months
排除标准
- •extensive metastatic disease
- •performance status of less than 70
- •children are excluded form the study
- •no uncontrolled intercurrent illness
- •no concurrent malignancy other than melanoma
- •pregnant or breast feeding women are excluded
- •women who are not post-menopausal and have a positive pregnancy test
- •life expectancy of less than 3 months
结局指标
主要结局
Late Gastrointestinal Toxicities
时间窗: 3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months
Late (Up to 3 months post-treatment to date of first progression or date of death, (whichever comes first-up to 36 months) Grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity attributable to Stereotactic Body Radiation Therapy (SBRT). Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria.
次要结局
- Local Progression Free Survival From SBRT(From date of randomization until the date of first documented progression or death from any cause (up to 36 months).)
- Change in Patient Reported Quality of Life (PR-QOL) Assessment at Baseline (Pre-treatment) and 3 Months (Post-Treatment)(Baseline (Pre-SBRT) and at 3 months (Post-SBRT))
- Linear Accelerator (Linac) Based SBRT Pain Control(3, 6, and 12 months after treatment)
- Linac Based SBRT Standardization(3, 6, and 12 months after treatment)
- FDG-PET Use for Planning and Estimation of Survival(3, 6, and 12 months after treatment and then annually thereafter)
- Toxicity for Patients With Chemotherapy, Surgery (Resection) and Radiation for Tumor Assessments(Up to 36 months)
- Toxicity for Patients With Chemotherapy and Radiation (no Resection)(Up to 36 months)
- Acute Gastrointestinal Toxicity(within 3 months of treatment)
- Local Progression Free Survival From SBRT(From date of randomization until the date of first documented progression or death from any cause (up to 36 months).)
- Linear Accelerator (Linac) Based SBRT Pain Control(3, 6, and 12 months after treatment)
- Local Progression Free Survival From Diagnosis(From date documented diagnosis to date of first documented local disease progression.)
- Change in Patient Reported Quality of Life (PR-QOL) Assessment at Baseline (Pre-treatment) and 3 Months (Post-Treatment)(Baseline (Pre-SBRT) and at 3 months (Post-SBRT))
- Linac Based SBRT Standardization(3, 6, and 12 months after treatment)
- FDG-PET Use for Planning and Estimation of Survival(3, 6, and 12 months after treatment and then annually thereafter)
- Toxicity for Patients With Chemotherapy, Surgery (Resection) and Radiation for Tumor Assessments(Up to 36 months)
- Toxicity for Patients With Chemotherapy and Radiation (no Resection)(Up to 36 months)